Status:
COMPLETED
Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Malignant Bilio-pancreatic Diseases
Eligibility:
All Genders
18+ years
Brief Summary
One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative to ERCP-based biliary decompression. In fact, even when performed by expert endoscopists, ERCP-based stenti...
Eligibility Criteria
Inclusion
- • subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ERCP failure.
Exclusion
- Age \< 18 y
- Contra-indication for endoscopy or interventional radiology
- Unsigned informing consent form, ICF
- Pregnancy
Key Trial Info
Start Date :
June 17 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04403893
Start Date
June 17 2020
End Date
December 31 2021
Last Update
May 4 2022
Active Locations (1)
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1
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089